追踪活动和适应在多站点阶段实践试验的癌症症状管理干预的追踪活动和适应
Jennifer L Ridgeway1,2, Andrea L Cheville3, Kristin J Fischer2
1Division of Health Care Delivery Research, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.
Contemporary clinical trials communications
|February 21, 2024
概括
在实用试验中跟踪干预调整对于评估至关重要. 本研究详细介绍了癌症症状管理试验中使用的强有力的跟踪方法,确定了关键的适应和实施策略.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床试验方法论 临床试验方法论
- 实施科学 实施科学
背景情况:
- 实用试验通常需要根据当地相关性调整干预措施.
- 追踪这些适应对于准确的评估至关重要.
- 这项研究重点是针对癌症症状管理的多站点,阶梯混合实用试验中的适应跟踪.
研究的目的:
- 描述干预调整和实施策略的系统跟踪方法.
- 为了记录在癌症症状管理试验中改善局部适应性和参与度而做出的变化.
- 通过识别有意义的调整和实施努力,为评估提供信息.
主要方法:
- 使用电子表格和数据库,记录研究活动,干预调整和实施策略.
- 使用了扩展的调整和修改报告框架 (FRAME) 和纵向实施战略跟踪系统 (LISTS).
- 开发了一个逻辑模型来绘制核心干预组件和适应时间表.
主要成果:
- 记录了187项研究活动;记录了11项干预调整,大多数是为改善适应或参与而计划的.
- 扩大干预角色,包括两个新的学科是一个关键的适应.
- 记录了33个实施策略,主要集中在利益相关者教育上.
结论:
- 一种多方面的跟踪方法和逻辑模型有助于识别重要的试验变化.
- 需要进一步改进,以减少跟踪负担,并提高系统的评估和决策的实用性.
- 强大的适应跟踪对于实用性试验评估的完整性至关重要.
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